Face PainPhase 4NCT00992108
Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques
A Phase 4 study testing lidocaine and chemodenervation in people with Face Pain, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of the neuromuscular junction. It has been proposed to be effective in spastic conditions of the head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Face Pain
- What is being tested?
- lidocaine and chemodenervation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are to have identifiable painful myofascial trigger points in the masseter, temporalis, and medial and lateral pterygoid muscles.
- Subjects will be examined by the principle investigators to determine if the individual is a suitable candidate for the study, based on active trigger points and willingness to participate in the study
Who cannot join
- Pregnant woman will be excluded from participation as potential risk is noted in product label indications. Individuals over the age of 65 will be excluded per product label indications that reflect lack of data in individuals over age 65.
Trial locations and contacts
1 site in 1 country.
About this study
Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of the neuromuscular junction. It has been proposed to be effective in spastic conditions of the head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4). However, only one randomized, double-blinded, placebo controlled trial has been completed involving 20 patients demonstrating both objective and subjective improvement in the BTX-A treated group over those treated with saline at one week, one month, and six months (5).
Currently, in most orofacial pain practices, when the diagnosis of masticatory myofascial pain in the head region is made, patients are treated with a standard myofascial protocol. This protocol involves stretching, application of moist heat, spray and stretch, and lidocaine trigger point injections into the masticatory muscles. This is considered the standard of care among most orofacial pain practioners.
Read more
There have been no randomized, double-blinded, head-to-head trials comparing BTX-A injections to lidocaine injections in the treatment of masticatory myofacial pain. Moreover, in all studies, muscles were targeted using surface landmarks with no confirmatory tests to guarantee the medication was administered to the intended muscle. In previous studies, the medial and lateral pterygoid muscles, important masticatory muscles that is often hyperactive in masticatory myofacial pain was not injected due to lack of palpable surface landmarks. Ultrasound and electromyography (EMG) guidance will help us locate these muscles.
The purpose of this study is to objectively measure functional improvement in patients with masticatory myofascial pain injected with lidocaine versus BTX-A. A pilot study enrolling 20 patients is proposed. 20 patients will be randomized to receive either BTX-A or lidocaine injections into the bilateral temporalis, masseter, and medial and lateral pterygoid. Objective and subjective clinical parameters will be measured. These include pain at rest and with chewing, maximum non-assisted and assisted mouth opening, protrusive and laterotrusive jaw movements, subjective efficacy of treatment, and side-effects of treatment. Patients will be assessed at baseline, one week, one month, and three months after the procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
1cc 1%
chemodenervationDrug
botulinum toxin
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | lidocaine injection group Receives: Drug: lidocaine |
| Botulinum | Experimental | Not described Receives: Drug: chemodenervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation."
Measured: 4 months
Secondary outcomes (3)
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation."
Measured: 6 weeks
Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold
measurements were obtained by placing examiner's index finger of the examiner on the area of the trigger point (hyperirritable areas on skeletal muscle with palpable taut bands of muscle fibers) and exerting pressure until there was whitening of the nail bed. Pressure pain levels were rated subjectively by the participant and coded numerically as mild (1), moderate (2) to severe (3).
Measured: baseline, 4 months
Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening
maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)
Measured: baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Lack of eligible patients willing and able to participate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Face PainStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marisa Chang, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992108
- Sponsor's protocol ID
- 8295968
- Status last verified
- Nov 2016
- First submitted
- 8 Oct 2009
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Botulinum Toxin Versus Lidocaine in Treating Masticatory Myofascial Face Pain Using Ultrasound and EMG Guided Techniques
- ClinicalTrials.gov ID
- NCT00992108
- Acronym / sponsor ID
- 8295968
- Conditions
- Face Pain
- Keywords
- Bruxism, Myofascial pain, EMG, Ultrasound, Masticatory myofascial face pain from bruxism and clenching
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible patients willing and able to participate
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Posted 29 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of the neuromuscular junction. It has been proposed to be effective in spastic conditions of the head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4). However, only one randomized, double-blinded, placebo controlled trial has been completed involving 20 patients demonstrating both objective and subjective improvement in the BTX-A treated group over those treated with saline at one week, one month, and six months (5).
Currently, in most orofacial pain practices, when the diagnosis of masticatory myofascial pain in the head region is made, patients are treated with a standard myofascial protocol. This protocol involves stretching, application of moist heat, spray and stretch, and lidocaine trigger point injections into the masticatory muscles. This is considered the standard of care among most orofacial pain practioners.
There have been no randomized, double-blinded, head-to-head trials comparing BTX-A injections to lidocaine injections in the treatment of masticatory myofacial pain. Moreover, in all studies, muscles were targeted using surface landmarks with no confirmatory tests to guarantee the medication was administered to the intended muscle. In previous studies, the medial and lateral pterygoid muscles, important masticatory muscles that is often hyperactive in masticatory myofacial pain was not injected due to lack of palpable surface landmarks. Ultrasound and electromyography (EMG) guidance will help us locate these muscles.
The purpose of this study is to objectively measure functional improvement in patients with masticatory myofascial pain injected with lidocaine versus BTX-A. A pilot study enrolling 20 patients is proposed. 20 patients will be randomized to receive either BTX-A or lidocaine injections into the bilateral temporalis, masseter, and medial and lateral pterygoid. Objective and subjective clinical parameters will be measured. These include pain at rest and with chewing, maximum non-assisted and assisted mouth opening, protrusive and laterotrusive jaw movements, subjective efficacy of treatment, and side-effects of treatment. Patients will be assessed at baseline, one week, one month, and three months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: lidocainelidocaine injection group |
| Botulinum | Experimental | Drug: chemodenervation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects are to have identifiable painful myofascial trigger points in the masseter, temporalis, and medial and lateral pterygoid muscles.
- Subjects will be examined by the principle investigators to determine if the individual is a suitable candidate for the study, based on active trigger points and willingness to participate in the study
Key exclusion criteria (1 listed)
- Pregnant woman will be excluded from participation as potential risk is noted in product label indications. Individuals over the age of 65 will be excluded per product label indications that reflect lack of data in individuals over age 65.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine1cc 1% | Drug | Lidocaine |
| chemodenervationbotulinum toxin | Drug | Botulinum |
Primary outcome
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
Time frame: 4 months
The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation."
3 secondary outcomes
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score
Time frame: 6 weeks
Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold
Time frame: baseline, 4 months
Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening
Time frame: baseline, 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa Chang, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine and chemodenervation in people with Face Pain, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.